Cidofovir injection 375 mg/mL vial Injection recalled over sterility concerns

Recall date

October 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Heritage Pharmaceuticals, Inc. recalls Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawa…

Recall number

D-0094-2019

FDA classification

Class II

Brand / firm

Heritage Pharmaceuticals, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31